Register Now
Log In
中文/English
About ITMCTR|Search Trials|About Us|News
Clinical Research on the Fire Dragon Jar Comprehensive Therapy for Postpartum Lactation Insufficiency with Qi-Xue Deficiency

注册号：

Registration number：

ITMCTR2025000594

最近更新日期：

Date of Last Refreshed on：

2025-03-26

注册时间：

Date of Registration：

2025-03-26

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

火龙罐综合疗法治疗气血虚弱型产后缺乳的临床研究

Public title：

Clinical Research on the Fire Dragon Jar Comprehensive Therapy for Postpartum Lactation Insufficiency with Qi-Xue Deficiency

注册题目简写：

English Acronym：

研究课题的正式科学名称：

火龙罐综合疗法治疗气血虚弱型产后缺乳的临床研究

Scientific title：

Clinical Research on the Fire Dragon Jar Comprehensive Therapy for Postpartum Lactation Insufficiency with Qi-Xue Deficiency

研究课题的正式科学名称简写：

Scientific title acronym：

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

刘慧华

研究负责人：

刘慧华

Applicant：

Liu Huihua

Study leader：

Liu Huihua

申请注册联系人电话：

Applicant telephone：

+86 182 5746 8891

研究负责人电话：

Study leader's telephone：

+86 182 5746 8891

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

553779526@qq.com

研究负责人电子邮件：

Study leader's E-mail：

553779526@qq.com

申请单位网址(自愿提供)：

Study leader's website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website
(voluntary supply)：

申请注册联系人通讯地址：

浙江省金华市中医医院妇产科护士站

研究负责人通讯地址：

浙江省金华市中医医院妇产科护士站

Applicant address：

Zhejiang Jinhua City Hospital of Traditional Chinese Medicine obstetrics and gynecology nurse station

Study leader's address：

Zhejiang Jinhua City Hospital of Traditional Chinese Medicine obstetrics and gynecology nurse station

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

浙江中医药大学附属金华中医院

Applicant's institution：

Jinhua Hospital of Traditional Chinese Medicine Zhejiang University of Chinese Medicine

是否获伦理委员会批准：

Approved by ethic committee：

伦理委员会批件文号：

Approved No. of ethic committee：

金华市中医医院伦审2025研第003号-批

伦理委员会批件附件：

Approved file of Ethical Committee：

View

批准本研究的伦理委员会名称：

金华市中医医院

Name of the ethic committee：

Jinhua Hospital of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2025/2/25 0:00:00

伦理委员会联系人：

王未寒

Contact Name of the ethic committee：

Wang Weihan

伦理委员会联系地址：

金华市中医医院科教科

Contact Address of the ethic committee：

Jinhua City Hospital of Traditional Chinese Medicine Science and education Department

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 579 8213 6871

伦理委员会联系人邮箱：

Contact email of the ethic committee：

kjc82136871@163.com

研究实施负责（组长）单位：

金华市中医医院

Primary sponsor：

Jinhua Hospital of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

浙江省金华市双溪西路439号

Primary sponsor's address：

No. 439 Shuangxi West Road Jinhua City Zhejiang Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

浙江

市(区县)：

金华市

Country：

Chinese

Province：

Zhejiang

City：

单位(医院)：

金华市中医医院

具体地址：

浙江省金华市双溪西路439号

Institution
hospital：

Jinhua Hospital of Traditional Chinese Medicine

Address：

No. 439 Shuangxi West Road Jinhua City Zhejiang Province

经费或物资来源：

自筹

Source(s) of funding：

self-raised

研究疾病：

产后缺乳

研究疾病代码：

Target disease：

Postpartum lactation

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段：

Study phase：

治疗新技术临床试验

New Treatment Measure Clinical Study

研究目的：

母乳是婴儿最理想的食物，充足和高质量的母乳是婴儿健康成长的保障。母乳喂养对母婴健康有极其重要的意义。根据调查显示全球纯母乳喂养并不理想：2019年在中国母乳喂养调查数据中显示，中国婴儿的纯母乳喂养率仅为29.2%，和预期目标60%仍存在较大距离。然而诸多原因可导致纯母乳喂养率低，其中产后缺乳与母亲早期断乳的关系密切。本研究采用火龙罐综合疗法治疗气血虚弱型产后缺乳，将研究对象60例随机分为实验组和对照组各30例，对照组采用缺乳常规护理+中药汤剂内服，每天一剂，连服14天；实验组在对照组的基础上采用火龙罐综合疗法，共干预9次，每次干预30-40min，14天为1个干预周期；观察两组在干预前后的泌乳量及乳房充盈情况、血清泌乳素（PRL）的水平、加奶量及产后缺乳气血亏虚证的中医症状评分。评价火龙罐综合疗法对气血虚弱型产后缺乳的影响。探究一种能改善产后缺乳的患者接受且依从性较高的中医适宜技术。

Objectives of Study：

Breast milk is the most ideal food for infants and adequate and high-quality breast milk is the guarantee for the healthy growth of infants. Breastfeeding is extremely important for the health of mothers and children. According to the survey global exclusive breastfeeding is not ideal: according to the data of China's breastfeeding survey in 2019 the exclusive breastfeeding rate of Chinese infants is only 29.2% which is still far from the expected target of 60%. However many reasons can lead to the low rate of exclusive breastfeeding among which postpartum lack of milk is closely related to early weaning. In this study the fire-dragon tank comprehensive therapy was used to treat postpartum deficiency of Qy-blood weakness. 60 cases of the study object were randomly divided into the experimental group and the control group 30 cases in each group. The control group was given routine nursing of deficiency of milk plus traditional Chinese medicine decoction one dose per day for 14 days. The experimental group was treated with fire-dragon tank combined therapy on the basis of the control group with a total of 9 intervention times each intervention of 30-40min 14 days for 1 intervention cycle; The lactation volume breast filling serum prolactin (PRL) level milk addition volume and TCM symptom score of postpartum deficiency of milk qi and blood deficiency were observed in the two groups before and after the intervention. To evaluate the effect of Huolong pot combined therapy on postpartum lactation in patients with weakness of qi and blood. To explore a suitable technique of traditional Chinese medicine that can improve the acceptance and compliance of postpartum patients with lactation deficiency.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

①符合上述气血虚弱型产后缺乳的中医及西医诊断标准；②患者自愿参加本研究，并已签署知情同意书；③患者年龄在23～40周岁之间，病程3-15天；④足月、单胎、无产科合并症和并发症；⑤患者愿意并签署知情同意者。

Inclusion criteria

① Meet the above Chinese medicine and Western medicine diagnostic criteria for postpartum lactation of Qi-blood weakness; ② The patient voluntarily participated in the study and had signed the informed consent; ③ Patients ranged in age from 23 to 40 years old and the course of disease was 3-15 days; (4) Full-term single no obstetric complications and complications; ⑤ The patient is willing and signs informed consent.

排除标准：

①乳房有炎症，如红肿、热痛，导致乳汁排出不畅者；②乳房生长发育不良或乳房有原发性疾病导致乳腺组织损伤而无法泌乳者；③曾进行乳房整形假体手术植入者；⑤患有严重疾病或恶性肿瘤、精神疾病患者不适合母乳喂养患者；⑥服用了影响乳汁分泌的药物者；⑦不能坚持治疗者；⑧对润肤油及蕲艾条过敏者。

Exclusion criteria：

① breast inflammation such as redness swelling heat pain resulting in poor milk discharge; (2) Breast growth dysplasia or primary breast disease resulting in breast tissue damage and inability to lactate; ③ Patients who have undergone breast plastic prosthesis surgery; (5) Patients with serious diseases or malignant tumors mental illness are not suitable for breastfeeding patients; ⑥ People who have taken drugs that affect milk secretion; ⑦ can not adhere to the treatment; ⑧ Allergic to skin oil and Chinese mugs.

研究实施时间：

Study execute time：

从From 2025-05-01

至To      2026-12-31

征募观察对象时间：

Recruiting time：

从From 2025-05-31

至To      2026-09-30

干预措施：

Interventions：

组别：

试验组

样本量：

30

Group：

Experimental group

Sample size：

干预措施：

常规护理的基础上给与火龙罐综合疗法

干预措施代码：

Intervention：

On the basis of routine nursing fire-dragon pot comprehensive therapy was given

Intervention code：

组别：

对照组

样本量：

30

Group：

Control group

Sample size：

干预措施：

产后缺乳常规护理，给予通乳丹加减中药口服，一日一剂，连服14天

干预措施代码：

Intervention：

Postpartum routine nursing of lack of milk, Tongru Dan plus minus traditional Chinese medicine orally, one dose a day, for 14 days

Intervention code：

样本总量 Total sample size ： 60

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

浙江

市(区县)：

金华

Country：

China

Province：

Zhejiang

City：

Jjinhua

单位(医院)：

金华市中医医院

单位级别：

三甲

Institution/hospital：

Jinhua Hospital of Traditional Chinese Medicine

Level of the institution：

Level 3A

测量指标：

Outcomes：

指标中文名：

血清泌乳素（PRL）的测定

指标类型：

次要指标

Outcome：

Determination of serum prolactin (PRL)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

乳房充盈

指标类型：

次要指标

Outcome：

breast engorgement

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

泌乳量

指标类型：

主要指标

Outcome：

Milk yield

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

产后缺乳气血虚弱证中医症状评分表

指标类型：

次要指标

Outcome：

Postpartum deficiency of milk Qi and blood weakness syndrome of traditional Chinese medicine symptom evaluation table

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

加奶量

指标类型：

次要指标

Outcome：

Milk addition

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血清

组织：

Sample Name：

serum

Tissue：

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note：

征募研究对象情况：

尚未开始

Not yet recruiting

年龄范围：

最小 23 岁
Min age years
最大 40 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

女性

Female

随机方法（请说明由何人用什么方法产生随机序列）：

随机双盲

Randomization Procedure (please state who generates the random number sequence and by what method)：

Random double blind

盲法：

所有人都不知道患者的具体分组，直到进行干预拆开信封后，实施干预的研究人员才知道患者的具体分组情况。干预结束后评估人员、数据登记人员和数据分析人员是不同的群体，避免研究人员主观因素产生的偏倚。

Blinding：

No one knows the specific grouping of patients until the intervention team opens the envelope and the researchers who implement the intervention know the specific grouping of patients. After the intervention evaluators data registrants and data analysts are different groups to avoid bias caused by subjective factors of researchers.

是否共享原始数据：

IPD sharing：

是

Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

2026-01-01 论文发表

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

2026-01-01 Publish an article

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

专门为本研究设计了病例记录表(Case Record Form, CRF)进行记录信息

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

A Case Record Form (CRF) was designed specifically for this study to record information.

数据管理委员会：

Data Managemen Committee：

有

Yes

研究计划书或研究结果报告发表信息
（杂志名称、期、卷、页，时间；或网址）：

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

back
Platform information
About ITMCTR
About Us
Register Trials
Frequently Asked Questions
Ethical Review
The public service
Search Trials
Join Us
ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above